System and method for securing tissue to bone

ABSTRACT

Disclosed herein are methods and devices for securing soft tissue to a rigid material such as bone. A tissue anchoring device is described that comprises an anchor body and a spreader such that tissue may be captured or compressed between outside surfaces on the anchor and inside surfaces of a bone tunnel to secure the tissue within the tunnel. Methods are described that enable use of the bone anchoring device to secure a tissue graft into the tibial and femoral bones during anterior cruciate ligament (“ACL”) reconstruction.

INCORPORATION BY REFERENCE TO ANY PRIORITY APPLICATION

This application is a divisional of U.S. application Ser. No. 17/336,216filed on Jun. 1, 2021, which is a continuation of U.S. application Ser.No. 15/893,958 filed on Feb. 12, 2018 (now U.S. Pat. No. 11,020,217),which is a divisional and claims the benefit and priority of U.S.application Ser. No. 14/774,663, filed Sep. 10, 2015 (now U.S. Pat. No.9,925,036), which claims the benefit and priority of PCT/US2014/022014filed on Mar. 7, 2014, which claims the benefit and priority of U.S.Provisional Application Ser. No. 61/801,255, filed Mar. 15, 2013, eachof which is hereby incorporated by reference in its respective entirety.

BACKGROUND OF INVENTION Field of the Invention

The present invention relates to medical devices and procedures. Moreparticularly, the present invention relates to devices and methods forsecuring soft tissue to a rigid material such as bone. Systems andmethods are disclosed herein of fixing tissue such as tendon or ligamentto bone in orthopedic procedures.

Description of the Related Art

There are several medical procedures where a surgeon needs to attachsoft connective tissue such as tendons or ligaments to bone. One commonexample is an anterior cruciate ligament (“ACL”) reconstruction, asurgical procedure usually performed for the treatment of a torn ACL.The ACL is one of four major ligaments of the knee. An ACLreconstruction may be performed as an isolated procedure, but is oftenperformed alongside the treatment of meniscus tears and cartilageinjuries as part of a multiple-repair surgery.

An ACL reconstruction is a procedure that replaces the injured ACL witha tissue graft generally formed from the patient's patellar tendon orhamstring tendon or the ligament of a cadaver. To perform an ACLreconstruction, a surgical procedure is used, typically requiring themultiple steps of: harvesting and sizing the tissue graft, securing thetissue graft to the end of a pin, removing the existing damaged ACL,drilling a tunnel that creates a bore through the tibial bone and ablind hole in the femoral bone, passing the pin and tissue graft throughthe bore and into the blind hole, and screwing a first anchor into theblind hole of the femur and a second anchor into the bore of the tibiato capture the tissue graft against the bone and solidly affix thetissue to the bone. Even as an isolated procedure, ACL reconstruction isdifficult to perform arthroscopically. Systems recently brought tomarket still require multiple steps and tools.

SUMMARY OF THE INVENTION

Disclosed herein are various embodiments of bone anchors and methods forperforming anterior cruciate ligament (ACL) repair that may address theaforementioned needs. In some embodiments of the present invention,there is provided a method of anterior cruciate ligament (ACL) repair,comprising forming a bone tunnel in a tibia, wherein the bone tunnelcomprises a proximal opening on one side of the tibia and a distalopening on an opposite side of the tibia, passing soft tissue throughthe bone tunnel, securing the soft tissue to a femur, inserting ananchor into a proximal opening of the bone tunnel to a position where adistal end of the anchor is adjacent to a distal opening of the bonetunnel, wherein the anchor comprises an expandable anchor body having aninternal cavity and a spreader, and sliding the expander into theinternal cavity, thereby causing at least a portion of the anchor bodyto expand outward, wherein upon completion of the expansion, at least aportion of the anchor body adjacent to the distal opening of the bonetunnel is expanded.

In some embodiments of the present invention, upon insertion of theanchor, the anchor extends substantially the entire length of the bonetunnel. In some embodiments upon expansion of the anchor, at least aportion of the anchor is not expanded outward. In further embodiments,the portion not expanded outward comprises an anchor tip.

In some embodiments of the present invention, there is provided a methodof ACL repair, comprising forming a bone tunnel in a tibia, wherein thebone tunnel comprises a proximal opening on one side of the tibia and adistal opening on an opposite side of the tibia, passing soft tissuethrough the bone tunnel, securing the soft tissue to a femur, insertingan anchor into a proximal opening of the bone tunnel to a position wherea distal end of the anchor is adjacent to a distal opening of the bonetunnel, wherein the anchor is greater than about 30 mm long andcomprises an expandable anchor body having an internal cavity and aspreader, and sliding the expander into the internal cavity, therebycausing at least a portion of the anchor body to expand outward, whereinupon completion of the expansion, at least a portion of the anchor bodyadjacent to the distal opening of the bone tunnel is expanded.

In some embodiments of the present invention, there is provided a methodof ACL repair, comprising forming a bone tunnel in a tibia, wherein thebone tunnel comprises a proximal opening on one side of the tibia and adistal opening on an opposite side of the tibia, passing soft tissuethrough the bone tunnel, securing the soft tissue to a femur, insertingan anchor into a proximal opening of the bone tunnel to a position wherea distal end of the anchor is adjacent to a distal opening of the bonetunnel, wherein the anchor is greater than about 35 mm long andcomprises an expandable anchor body having an internal cavity and aspreader, and sliding the expander into the internal cavity, therebycausing at least a portion of the anchor body to expand outward, whereinupon completion of the expansion, at least a portion of the anchor bodyadjacent to the distal opening of the bone tunnel is expanded.

In some embodiments of the present invention, there is provided a methodof ACL repair, comprising forming a bone tunnel in a tibia, wherein thebone tunnel comprises a proximal opening on one side of the tibia and adistal opening on an opposite side of the tibia, passing soft tissuethrough the bone tunnel, securing the soft tissue to a femur, insertingan anchor into a proximal opening of the bone tunnel to a position wherea distal end of the anchor is adjacent to a distal opening of the bonetunnel, wherein the anchor is greater than about 40 mm long andcomprises an expandable anchor body having an internal cavity and aspreader, and sliding the expander into the internal cavity, therebycausing at least a portion of the anchor body to expand outward, whereinupon completion of the expansion, at least a portion of the anchor bodyadjacent to the distal opening of the bone tunnel is expanded.

In other embodiments of the present invention, there is provided amethod of anterior cruciate ligament (ACL) repair, comprising forming abone tunnel in a tibia, wherein the bone tunnel comprises a proximalopening on one side of the tibia and a distal opening on an oppositeside of the tibia, passing soft tissue through the bone tunnel, securingthe soft tissue to a femur, inserting an anchor into a proximal openingof the bone tunnel to a position where a distal end of the anchor isadjacent to a distal opening of the bone tunnel, wherein the anchorcomprises an expandable anchor body having an internal cavity and aspreader, and inserting the expander into the internal cavity, therebycausing at least a portion of the anchor body to expand outward, whereinupon completion of the expansion, the expanded portion of the anchorbody is expanded substantially uniformly along its length.

In some embodiments of the present invention upon insertion of theanchor, the anchor extends substantially the entire length of the bonetunnel. In some embodiments upon expansion of the anchor, at least aportion of the anchor is not expanded outward. In further embodimentsthe portion not expanded outward comprises an anchor tip.

In some embodiments of the present invention, there is provided a methodof ACL repair, comprising forming a bone tunnel in a tibia, wherein thebone tunnel comprises a proximal opening on one side of the tibia and adistal opening on an opposite side of the tibia, passing soft tissuethrough the bone tunnel, securing the soft tissue to a femur, insertingan anchor into a proximal opening of the bone tunnel to a position wherea distal end of the anchor is adjacent to a distal opening of the bonetunnel, wherein the anchor is greater than about 30 mm long andcomprises an expandable anchor body having an internal cavity and aspreader, and inserting the expander into the internal cavity, therebycausing at least a portion of the anchor body to expand outward, whereinupon completion of the expansion, the expanded portion of the anchorbody is expanded substantially uniformly along its length.

In some embodiments of the present invention, there is provided a methodof ACL repair, comprising forming a bone tunnel in a tibia, wherein thebone tunnel comprises a proximal opening on one side of the tibia and adistal opening on an opposite side of the tibia, passing soft tissuethrough the bone tunnel, securing the soft tissue to a femur, insertingan anchor into a proximal opening of the bone tunnel to a position wherea distal end of the anchor is adjacent to a distal opening of the bonetunnel, wherein the anchor is greater than about 35 mm long andcomprises an expandable anchor body having an internal cavity and aspreader, and inserting the expander into the internal cavity, therebycausing at least a portion of the anchor body to expand outward, whereinupon completion of the expansion, the expanded portion of the anchorbody is expanded substantially uniformly along its length.

In some embodiments of the present invention, there is provided a methodof ACL repair, comprising forming a bone tunnel in a tibia, wherein thebone tunnel comprises a proximal opening on one side of the tibia and adistal opening on an opposite side of the tibia, passing soft tissuethrough the bone tunnel, securing the soft tissue to a femur, insertingan anchor into a proximal opening of the bone tunnel to a position wherea distal end of the anchor is adjacent to a distal opening of the bonetunnel, wherein the anchor is greater than about 40 mm long andcomprises an expandable anchor body having an internal cavity and aspreader, and inserting the expander into the internal cavity, therebycausing at least a portion of the anchor body to expand outward, whereinupon completion of the expansion, the expanded portion of the anchorbody is expanded substantially uniformly along its length.

In other embodiments of the present invention, there is provided amethod of anterior cruciate ligament (ACL) repair, comprising forming abone tunnel in a tibia, wherein the bone tunnel comprises a proximalopening on one side of the tibia and a distal opening on an oppositeside of the tibia, passing soft tissue through the bone tunnel, securingthe soft tissue to a femur, measuring the length of the bone tunnel,selecting an anchor from a plurality of possible anchors based on themeasurement, inserting the anchor into a proximal opening of the bonetunnel to a position where a distal end of the anchor is adjacent to adistal opening of the bone tunnel, wherein the anchor comprises anexpandable anchor body having an internal cavity and a spreader, andinserting the spreader into the internal cavity, thereby causing atleast a portion of the anchor body to expand outward, wherein uponcompletion of the expansion, at least a portion of the anchor bodyadjacent to the distal opening of the bone tunnel is expanded. In someembodiments selecting the anchor comprises selecting a length of anchoramong a plurality of possible lengths.

In other embodiments of the present invention, there is provided anexpandable bone anchor, comprising an anchor body and a spreader. Theanchor body comprises a distal tapered anchor tip and a plurality ofrigid side portions extending proximally from the anchor tip, each sideportion coupled to the anchor tip through a double hinge. The spreaderis configured to advance distally into the anchor body, thereby causingthe rigid side portions to expand outward.

In some embodiments the spreader is coupled to the side portions. Insome embodiments the spreader is slidably coupled to the side portions.In further embodiments the spreader comprises a plurality oflongitudinal tracks and each side portion is coupled to one of thetracks such that the side portions can slide longitudinally along thetracks.

In some embodiments of the present invention, there is provided anexpandable bone anchor, comprising an anchor body and a spreader. Theanchor body comprises a distal tapered anchor tip and a plurality ofrigid side portions extending proximally from the anchor tip, each sideportion coupled to the anchor tip through a double hinge. The spreaderis configured to advance distally into the anchor body, thereby causingthe rigid side portions to expand outward, wherein the spreadercomprises at least a portion that is tapered distally.

In some embodiments of the present invention, there is provided anexpandable bone anchor, comprising an anchor body and a spreader. Theanchor body comprises a distal tapered anchor tip and a plurality ofrigid side portions extending proximally from the anchor tip, each sideportion coupled to the anchor tip through a double hinge. The spreaderis configured to advance distally into the anchor body, thereby causingthe rigid side portions to expand outward. In some embodiments theanchor tip comprises a proximal locking member and the spreadercomprises a distal locking member, wherein the two locking members areconfigured to lock together upon maximal distal advancement of thespreader. In further embodiments, the proximal locking member on the tipcomprises a post having an outwardly protruding ridge and the distallocking member on the spreader comprises a hollow cylinder configured toreceive the post. In further embodiments the hollow cylinder comprises agroove on an inside surface configured to receive the protruding ridge.In further embodiments the hollow cylinder comprises expandable tabs.

In some embodiments of the present invention, there is provided anexpandable bone anchor, comprising an anchor body and a spreader. Theanchor body comprises a distal tapered anchor tip and a plurality ofrigid side portions extending proximally from the anchor tip, each sideportion coupled to the anchor tip through a double hinge. The spreaderis configured to advance distally into the anchor body, thereby causingthe rigid side portions to expand outward, wherein upon maximalexpansion, the rigid side portions are expanded to a substantiallyuniform extent along their length.

In other embodiments of the present invention, there is provided anexpandable bone anchor, comprising an anchor body and a spreader. Theanchor body comprises a distal tapered anchor tip, a plurality of firstexpandable side portions, and a plurality of second expandable sideportions. The plurality of first expandable side portions are positionedat a proximal end of the anchor body, wherein the first expandable sideportions expand by bending outward such that the first expandable sideportion extends outward to a greater extent at its proximal portion thanat its distal portion. The plurality of second expandable side portionsare positioned distally of the first expandable side portions, whereinthe second expandable side portions expand by bending outward such thatthe second expandable side portion extends outward to a greater extentat its distal portion than at its proximal portion. The spreader isconfigured to advance distally into the anchor body, thereby causing thefirst and second expandable side portions to expand outward.

In some embodiments the first and second expandable side portionscomprise bone-engaging features. In further embodiments the bone engagefeatures comprise teeth. In some embodiments the bone engage featurescomprise ridges.

In some embodiments of the present invention, there is provided anexpandable bone anchor, comprising an anchor body and a spreader. Theanchor body comprises a distal tapered anchor tip, a plurality of firstexpandable side portions, and a plurality of second expandable sideportions. The plurality of first expandable side portions are positionedat a proximal end of the anchor body, wherein the first expandable sideportions expand by bending outward such that the first expandable sideportion extends outward to a greater extent at its proximal portion thanat its distal portion. The plurality of second expandable side portionsare positioned distally of the first expandable side portions, whereinthe second expandable side portions expand by bending outward such thatthe second expandable side portion extends outward to a greater extentat its distal portion than at its proximal portion. The spreader isconfigured to advance distally into the anchor body, thereby causing thefirst and second expandable side portions to expand outward, wherein thefirst and second expandable side portion is formed by cuts in a sidewall of the anchor body. In some embodiments the anchor body tapersdistally upon substantially its whole length. In some embodiments theanchor tip has a hemispherical shape. In some embodiments the anchor tiphas a conical shape. In some embodiments the second expandable sideportions comprise a protrusion extending into a central cavity withinthe anchor body, wherein advancement of the spreader into the centralcavity causes the spreader to contact the protrusion, thereby causingthe second expandable side portions to expand outward.

In some embodiments of the present invention, there is provided anexpandable bone anchor, comprising an anchor body and a spreader. Theanchor body comprises a distal tapered anchor tip, a plurality of firstexpandable side portions, and a plurality of second expandable sideportions. The plurality of first expandable side portions are positionedat a proximal end of the anchor body, wherein the first expandable sideportions expand by bending outward such that the first expandable sideportion extends outward to a greater extent at its proximal portion thanat its distal portion. The plurality of second expandable side portionsare positioned distally of the first expandable side portions, whereinthe second expandable side portions expand by bending outward such thatthe second expandable side portion extends outward to a greater extentat its distal portion than at its proximal portion. The spreader isconfigured to advance distally into the anchor body, thereby causing thefirst and second expandable side portions to expand outward, wherein thespreader comprises at least a portion that is tapered distally.

In some embodiments of the present invention, there is provided anexpandable bone anchor, comprising an anchor body and a spreader. Theanchor body comprises a distal tapered anchor tip, a plurality of firstexpandable side portions, and a plurality of second expandable sideportions. The plurality of first expandable side portions are positionedat a proximal end of the anchor body, wherein the first expandable sideportions expand by bending outward such that the first expandable sideportion extends outward to a greater extent at its proximal portion thanat its distal portion. The plurality of second expandable side portionsare positioned distally of the first expandable side portions, whereinthe second expandable side portions expand by bending outward such thatthe second expandable side portion extends outward to a greater extentat its distal portion than at its proximal portion. The spreader isconfigured to advance distally into the anchor body, thereby causing thefirst and second expandable side portions to expand outward, wherein thespreader has a substantially constant diameter along its length. In someembodiments the spreader comprises a circumferential ridge positioned ator adjacent to its proximal end.

BRIEF DESCRIPTION OF THE DRAWINGS

The above-mentioned aspects, as well as other features, aspects, andadvantages of the present technology will now be described in connectionwith various embodiments, with reference to the accompanying drawings.The illustrated embodiments, however, are merely examples and are notintended to be limiting.

FIG. 1 depicts a perspective proximal view of one embodiment of a tissueanchoring device in an unexpanded/undeployed state.

FIG. 2A depicts a perspective distal view of one embodiment of an anchorbody in an unexpanded state.

FIG. 2B depicts a perspective proximal view of one embodiment of ananchor body in an unexpanded state.

FIG. 3A shows a perspective proximal view of one embodiment of aspreader.

FIG. 3B shows a perspective distal view of one embodiment of a spreader.

FIG. 3C shows a cross-sectional view of one embodiment of a spreader.

FIG. 4 shows a perspective view of one embodiment of a distal tip of ananchor body.

FIG. 5A depicts a perspective view of one embodiment of a tissueanchoring device in an unexpanded/undeployed state.

FIG. 5B depicts a perspective proximal view of one embodiment of atissue anchoring device in an expanded/deployed state.

FIG. 6A shows a perspective view of one embodiment of a tissue anchoringdevice in an unexpanded/undeployed state.

FIG. 6B shows a perspective view of one embodiment of a tissue anchoringdevice in an expanded/deployed state.

FIG. 6C shows a front view of one embodiment of a tissue anchoringdevice in the expanded/deployed state.

FIG. 7A shows a cross-sectional view of one embodiment of a tissueanchoring device in which the tissue anchoring device has partiallydeployed or expanded.

FIG. 7B shows a cross-sectional view of another embodiment of a tissueanchoring device in which the tissue anchoring device has partiallydeployed or expanded.

FIG. 8A depicts a perspective distal view of one embodiment of an anchorbody in an unexpanded/undeployed state.

FIG. 8B depicts a perspective proximal view of one embodiment of ananchor body in an unexpanded/undeployed state.

FIG. 9A depicts a perspective distal view of one embodiment of aspreader.

FIG. 9B depicts a perspective proximal view of one embodiment of aspreader.

FIG. 10A depicts a side view of one embodiment of a tissue anchoringdevice attached to an inserter tool and covered by a sleeve.

FIG. 10B depicts a perspective view of one embodiment of a tissueanchoring device attached to an inserter tool with the sleeve retracted.

FIG. 11 depicts a perspective distal view of one embodiment of a tissueanchoring device in an unexpanded/undeployed state.

FIG. 12 depicts a perspective distal view of one embodiment of ananchoring body in an unexpanded/undeployed state.

FIG. 13 depicts a perspective proximal view of one embodiment of aspreader.

FIG. 14 depicts a perspective distal view of one embodiment of a tissueanchoring device in an expanded/deployed state.

FIG. 15A shows an exploded view of one embodiment of an inserter tool.

FIG. 15B shows a perspective view of one embodiment of an inner rodcomponent of an insertion tool.

FIG. 15C shows a perspective view of one embodiment of an outer tubecomponent of an insertion tool.

FIG. 15D shows a side view of one embodiment of a handle component of aninsertion tool.

FIG. 15E shows a perspective view of one embodiment of a handlecomponent of an insertion tool.

FIG. 15F shows a perspective view of one embodiment of an actuator shaftcomponent of an insertion tool.

FIG. 15G shows a perspective view of one embodiment of a deployment knobcomponent of an insertion tool.

FIG. 16A shows a perspective view of one embodiment of a femoral tissuecapture anchor device in an undeployed or unexpanded state.

FIG. 16B shows a perspective view of one embodiment of a femoral tissuecapture anchor device in a deployed or expanded state.

FIG. 17 shows a perspective view of one embodiment of a tissue anchoringdevice comprising a tissue capture suture loop.

FIGS. 18A-18D depict four frontal views of the bones surrounding thehuman knee and one embodiment of a method of securing soft tissue to thebones using a tissue anchoring device.

DETAILED DESCRIPTION OF THE CERTAIN EMBODIMENTS

In the following detailed description, reference is made to theaccompanying drawings, which form a part of the present disclosure. Inthe drawings, similar symbols typically identify similar components,unless context dictates otherwise. The illustrative embodimentsdescribed in the detailed description, drawings, and claims are notmeant to be limiting. Other embodiments may be utilized, and otherchanges may be made, without departing from the spirit or scope of thesubject matter presented herein. It will be readily understood that theaspects of the present disclosure, as generally described herein, andillustrated in the Figures, can be arranged, substituted, combined, anddesigned in a wide variety of different configurations, all of which areexplicitly contemplated and form part of this disclosure.

The terminology used herein is for the purpose of describing particularembodiments only and is not intended to be limiting of the disclosure.It will be understood by those within the art that if a specific numberof a claim element is intended, such intent will be explicitly recitedin the claim, and in the absence of such recitation, no such intent ispresent. For example, as used herein, the singular forms “a”, “an” and“the” are intended to include the plural forms as well, unless thecontext clearly indicates otherwise. As used herein, the term “and/or”includes any and all combinations of one or more of the associatedlisted items. It will be further understood that the terms “comprises,”“comprising,” “have,” “having,” “includes,” and “including,” when usedin this specification, specify the presence of stated features,integers, steps, operations, elements, and/or components, but do notpreclude the presence or addition of one or more other features,integers, steps, operations, elements, components, and/or groupsthereof. Expressions such as “at least one of,” when preceding a list ofelements, modify the entire list of elements and do not modify theindividual elements of the list.

To assist in the description of the devices and methods describedherein, some relational and directional terms are used. As recitedwithin this disclosure, the “longitudinal axis” of a bone or componentis the elongated axis running through the length of the bone orcomponent.

“Connected” and “coupled,” and variations thereof, as used hereininclude direct connections, such as being contiguously formed with, orglued, or otherwise attached directly to, on, within, etc. anotherelement, as well as indirect connections where one or more elements aredisposed between the connected elements. “Connected” and “coupled” mayrefer to a permanent or non-permanent (i.e., removable) connection.

“Secured” and variations thereof as used herein include methods by whichan element is directly secured to another element, such as being glued,screwed, or otherwise fastened directly to, on, within, etc. anotherelement, as well as indirect means of securing two elements togetherwhere one or more elements are disposed between the secured elements.

“Proximal” and “distal” are relational terms used herein to describeposition from the perspective of a medical professional positioning atissue anchoring device. For example, as compared to “distal,” the term“proximal” refers to a position that is located more closely to themedical professional once inserted or implanted during surgery. Often,the proximal end of the fixation device includes, for example, the endthat abuts an insertion tool. The distal end opposes the proximal endand often includes, for example, the end configured to be pushedfurthest into a bone tunnel in a patient.

Embodiments disclosed herein relate to tissue anchoring devices andmethods of anchoring soft tissue, such as for example, tendons orligaments, to bone. The tissue anchoring devices of the presentdisclosure are each configured with multiple fixation sites along thelength of the device.

Some embodiments disclosed herein relate generally to anchors for use inanchoring tissue or objects in a body. More specifically, someembodiments disclosed herein relate generally to anchors for use inanchoring soft tissue to bone in a body. Also some elements relate toindividual components and subcomponents of the systems described herein,as well as methods of making and using the same. Some embodimentsadditionally relate to kits and components used in connection with theanchor. Although the following embodiments refer to the use of an anchorin anchoring tissue, a person of skill in the art will recognize that ananchor can be used to anchor any range of items within a body.

Various embodiments disclosed herein relate to anchors configured toattach soft tissue to bone, such as, for example, to attach an anteriorcruciate ligament (“ACL”) graft within a bone tunnel of a tibial bone.As described in more detail below with reference to individualembodiments, various anchors disclosed herein are configured to extendthrough substantially the length a bone tunnel. In some suchembodiments, the anchors are configured to provide for expansion andfixation along the length of the anchor. In other embodiments disclosedherein, the anchors are configured to provide for expansion and fixationat various points along the length of the anchor.

FIG. 1 depicts a perspective view of one embodiment of a tissueanchoring device 100. The tissue anchoring device 100 of the currentembodiment includes an anchor body 200 and a spreader 300. The spreader300 is configured to slidably fit within a central bore of the anchorbody 200.

The anchor body 200, shown in more detail in FIGS. 2A and 2B, includesfour panels 210 (i.e., rigid side portions). In other embodiments, adifferent number of panels 210 may be present, such as, for example,three, five, six, seven, or eight panels 210. In various embodiments,when the panels 210 are in a first, unexpanded position, each panel 210abuts a neighboring panel 210 on at least two sides. Each panel 210 hasan outer surface 212 and an inner surface 214. In some embodiments, theouter surfaces 212 of the panels 210 together define the at least aportion of the shape of the anchor body 200. The outer surface 212 ofeach panel 210 includes one or more flat faces (e.g., faces 213 a, 213b, and 213 c). In such embodiments, when the panels 210 are in anunexpanded position, their outer surfaces 212 form a polyhedron. Inother embodiments, the outer surface 212 of each panel 210 has a roundedface, and together the outer surfaces 212 of the panels 210 form acylinder in an unexpanded position. In other embodiments, such as inFIG. 2A, the panels 210 have both rounded faces 213 a, 213 c andnon-rounded faces 213 b on the outer surface 212. In variousembodiments, when the panels 210 are in an unexpanded position, thetissue anchoring device 100 is in a streamlined position such that thereis little to no protrusion of the panels 210 radially outward. In someembodiments, the panels 210 are substantially rigid and do not flexduring operation.

As shown in FIG. 2A, in various embodiments, the inner surfaces 214 ofthe panels 210 surround and define a central bore 265. Additionally, insome embodiments, the inner surface 214 of each panel 210 has aplurality of faces. For example, as shown in FIG. 2B, the inner surface214 of some embodiments includes at least three faces (e.g., faces 215a, 215 b, and 215 c), which together define a groove 220. As describedin more detail below, in various embodiments, the groove 220 isconfigured to receive a protrusion or track of the spreader 300.

In some embodiments, the panels 210 and the central bore 265 extendnearly the entire length of the anchor body 200. In some suchembodiments, the anchor body 200 includes a distal tip 260 coupled to adistal end of the panels 210, which limits the panels 210 from actuallyextending the entire length of the anchor body 200. In variousembodiments, the distal tip 260 is closed and rounded. As shown in FIG.2B, each panel 210 is attached to the distal tip 260 via a hinge element225. The distal tip 260 of some embodiments acts as a base of direct orindirect connection for the plurality of panels 210. In someembodiments, each hinge element 225 includes two pivoting connections(i.e., forming a double hinge)—a distal pivot 224 at a distal side ofthe hinge element 225, pivotally connecting the hinge element 225 to thedistal tip 260, and a proximal pivot 226 at a proximal side of the hingeelement 225, pivotally connecting the hinge element 225 to a panel 210.

In some embodiments, the panels 210 are configured to move from anunexpanded position to an expanded position via pivoting about thedistal pivot 224 and the proximal pivot 226. In various embodiments, thepanels 210 are urged to move from the unexpanded position to theexpanded position upon insertion of a spreader 300 into the central bore265 of the anchor body 200. The spreader 300, shown in more detail inFIGS. 3A-3C, is shaped and configured to facilitate displacement of thepanels 210 of the anchor body 200.

FIG. 3A shows a perspective proximal view of a spreader and FIG. 3Bshows a perspective distal view, and FIG. 3C shows a cross-sectionalview of the spreader. The spreader 300 of FIGS. 3A-3C has asubstantially tubular body 310 with tracks 320 disposed on an outersurface 312 of the tubular body 310. The tracks 320 of some embodimentsrun longitudinally along the outer surface 312 from a distal portion ofthe spreader 300 to a proximal portion of the spreader 300. In someembodiments, the tracks 320 are complementary in placement and shape tothe grooves 220 of the anchor body 200, and the tracks 320 areconfigured to fit within the grooves 220. The grooves 220 and the tracks320 may include additional complementary features such as ridges 321,indentations 322, bumps 323, dimples, protrusions, recesses, and thelike, designed to lock the track 320 within the groove 220. When thetrack 320 of the spreader 300 is locked within the groove 220 of theanchor body 200, axial displacement and rotation of the spreader 300relative to the anchor body 200 is limited. Longitudinal displacement ofthe track 320 relative to the groove 220 is still possible in the lockedposition. It will be appreciated by those skilled in the art that insome embodiments, the complementary features can be reversed such thatthe anchor body 200 includes a set of tracks or protrusions and thespreader 300 includes a set of grooves or recesses.

In various embodiments, the tracks 320 are non-uniformly elevated fromthe outer surface 312 of the tubular body 310 along a length of thespreader 300. For example, in some embodiments, such as the embodimentof FIGS. 3A and 3B, each of the tracks 320 is disposed on a wedge-likeprojection 330 (hereinafter, a “wedge”), which extends radially outwardfrom the tubular body 310. In various embodiments, the wedge 330 extendsmost radially outward at a proximal end of the spreader 300 and tapersradially inward in the distal direction.

Also shown in FIG. 3A is a depression 316 (e.g., a groove)circumferentially arranged along an inner surface 314 of the spreader300 at the distal end of the spreader 300. The depression 316 isconfigured to engage with a portion of the distal tip 260, as describedin more detail below. In some embodiments, the depression 316 is locatedon or within one or more bendable tabs 318. The bendable tabs 318 aredefined by a plurality of cuts 319 made into a distal end of the tubularbody 310. The bendable tabs are configured to bend outwardly, bendingfrom a base of the cuts 319, when the spreader 300 makes contact with adistal tip 260 of the anchor body.

Additionally, as shown best in FIGS. 3B and 3C, in various embodiments,the spreader 300 has an opening 380 leading into an inner channel 390configured to receive and couple to an insertion tool. One embodiment ofan insertion tool 1000 is discussed in more detail below.

One embodiment of a distal tip 260 of an anchor body 200 is depicted inFIG. 4 . In various distal tip embodiments, the distal tip issubstantially closed and rounded to create a streamlined design. Theshape of the distal tip 260 facilitates insertion of the anchor body 200into a bone tunnel and helps the anchor body 200 slide around softtissue positioned within the bone tunnel without causing injury to thetissue. A small hole 290 may advantageously be provided in the center ofthe distal tip 260 to facilitate engagement of the anchor body 200 withan insertion tool. The small hole 290 may be surrounded by threadsconfigured to mate with threads on an inner rod of the insertion tool.In some embodiments, the distal tip 260 includes a lip 262 (e.g., aprotruding ridge) configured engage the depression 316 of the spreader300. Engagement between the depression 316 of the spreader 300 and thelip 262 of the distal tip 260 limits longitudinal movement of thespreader 300 and secures the tissue anchor device 100 in an expandedstate. The anchor body tip may additionally include holes, pins, and orother features 266 for attaching the hinge element 225 to the distal tip260 about a proximal pivot 226.

As shown in FIG. 5A, in various embodiments, the distal end of thespreader 300 is configured to enter the central bore 265 at a proximalend of the anchor body 200. In the provided illustration, the spreader300 has entered the central bore, but has not been advancedsubstantially into the central bore; as a result, the panels 210 arestill in an unexpanded position. The spreader 300 is configured tocontinue advancing distally deeper into the central bore by slidingwithin the grooves 220 of the anchor body 200. The spreader 300 isconfigured to urge the panels 210 of the anchor body 200 radiallyoutward relative to the central bore 265 upon insertion of the spreader300 into the central bore as shown in FIG. 5B, where the panels 210 arein an expanded position.

With the anchor body 200 and the spreader 300 aligned such that thetracks 320 of the spreader 300 are at least partially disposed withinthe grooves 220 of the anchor body 200, sliding the spreader 300 intothe central bore causes the panels 210 to be displaced outward,following the taper of the spreader 300. This outward displacementcauses the panels 210 to separate from each other and causes the anchorbody 200 to expand. In various embodiments, the panels 210 areconfigured to engage with soft tissue and bone when the panels 210 arepivoted to an expanded position, fixedly securing the tissue anchoringdevice 100 and the soft tissue within a bone tunnel. As shown in FIG.5B, in various embodiments, the entire length of each panel 210 isdisplaced outwardly when the panels 210 arc in an expanded position. Theoutward displacement is possible due to pivoting about the proximalpivot 226 and the distal pivot 224.

In some embodiments, distal movement of the spreader 300 within theanchor body 200 leads primarily to pivoting about the proximal pivot 226as the panels 210 are urged further outward by the increasing diameterof the advancing wedge 330. In some such embodiments, the spreader 300can be inserted into the central bore of the anchor body 200 until thedepression 316 of the spreader 300 engages with the lip 262 of thedistal tip 260 (as shown in FIG. 3C and FIG. 4 , respectively). Uponengagement of the lip 262 with the depression 316, contact is madebetween the distal end of the spreader 300 and the hinge elements 225,and a force is applied to the hinge elements 225, urging them to swingradially outward and pivot about the distal pivot 224. The panels 210transition to a fully expanded position when the hinge element 225swings outward about the distal pivot 224. In such an expanded position,the panels 210 extend radially outward from the anchor body 200. In someembodiments, each panel 210 undergoes relatively uniform expansion alongthe length of the panel 210. In other embodiments, as depicted in FIG.5B, the panels 210 expand to a greater extent at their proximal end ascompared to their distal end.

In embodiments described herein, the outward displacement of the panels210 and resultant expansion of the anchor body 200 is achieved withoutthe need for applying any torque to the tissue anchoring device 100.Thus, advantageously, insertion and expansion of the tissue anchoringdevices 100 disclosed herein is likely to prevent any twisting orturning of the soft tissue within a bone tunnel.

In various embodiments, the tissue anchoring device 100 is inserted intoa bone tunnel with the aid of an inserter tool, for example, insertertool 3000. More details about insertion tool 3000 are provided below.

Another embodiment of a tissue anchoring device 1100 is depicted in FIG.6A. The anchor body 1200 is comprised of a tubular wall 1210 defining acentral bore and having compressible tabs 1220. In one embodiment thetubular wall 1210 is uniformly tubular in that it comprises a uniformdiameter. The compressible tabs 1220 are configured to engage with softtissue and bone, fixedly securing the anchor body 1200 and the softtissue in the bone. In some embodiments, the compressible tabs compriseone or more teeth 1230 which are configured to further engage with thetissue and bone. The number of compressible tabs 1220 and teeth 1230 canvary. The compressible tabs are affixed to the tubular wall along anedge 1240. The edge 1240 is configured to allow pivotal movement aboutthe tubular wall such that the compressible tabs are bendable between acompressed state and an expanded state. The tissue anchoring device alsocomprises a spreader 1300, which is insertable into the central bore atthe anchor body's proximal end 1250 and configured to urge thecompressible tabs 1220 radially outward relative to the tubular wall1210 upon insertion of the spreader into the central bore. In FIG. 6A,the spreader 1300 is in its undeployed or uninserted state such that thecompressible tabs 1220 are collapsed and in their compressible state. Inthe embodiment depicted in FIG. 6A, when the compressible tabs 1220 arein their compressed state, the tissue anchoring device 1100 is in astreamlined position such that there is little to no protrusion of theteeth 1230 radially outward beyond the tubular wall.

In the tissue anchoring device embodiment of FIG. 6A, the tissueanchoring device 1100 also includes a proximal-most portion 1205, whichis outwardly expandable. Expansion slots 1206 are cut into the anchorbody 1200 at the proximal end and extend in a distal direction such thatthe outwardly expandable proximal portion 1205 comprises a plurality ofexpandable segments 1207 that are disconnected from each other. Eachexpandable segment 1207 is connected to the remainder of the anchor body1200 (i.e., to a non-expanding distal portion of the anchor body 200) ata distal end of each respective expandable segment 1207. In the depictedembodiment, the expandable segments 1207 are configured to bend radiallyoutward when the spreader 1300 is fully advanced distally into thecentral bore 1265 of the anchor body 1200. In some embodiments, contactbetween an inner surface of the anchor body 1200 and a ridge 1325 of thespreader 1300 creates a force that urges the expandable segments 1207radially outward.

In some embodiments, the tissue anchor 1100 is configured such that,when the tissue anchor 1100 is placed in a properly-sized bone hole, theoutwardly expandable proximal-most portion 1205 is positioned within thecortical layer of bone near the aperture of a bone tunnel. In suchembodiments, the expandable segments 1207 may be tailored to expand intothe cortical layer and provide for cortical fixation. In otherembodiments, the expandable segments 1207 may be configured for corticaland subcortical engagement. In various embodiments, each expandablesegment 1207 has a sharp edge, one or more ridges, teeth, or otherprotrusions 1208, which facilitate engagement of the expandable segment1207 with surrounding bone.

One embodiment of the tissue anchoring device is also depicted in FIG.6B. FIG. 6B shows a perspective view in which the spreader 1300 has beeninserted into the central bore of the anchor body 1200, thus moving thecompressible tabs 1220 into their expanded state. In such an expandedstate, the teeth 1230 extend radially outward from the anchor body 1200and are configured to engage with bone and fixedly secure the tissueanchoring device 1100 within the bone. In the embodiment of FIG. 6B, thecompressible tabs are positioned along circumferential rows. A first row1270 contains compressible tabs located along a first axial position,and a second row 1280 contains compressible tabs located along a secondaxial position. In some embodiments, the first row of tabs 1270 isoffset circumferentially relative to the second row of tabs 1280 suchthat no two compressible tabs 1220 share the same longitudinalalignment. Such a configuration facilitates capture and fixation of asoft tissue by hindering slippage of the soft tissue between thecompressible tabs.

FIG. 6C provides a front view of the embodiment described in FIG. 6B.FIG. 6C depicts compressible tabs 1230 in their expanded state and afirst row of compressible tabs 1270 offset circumferentially from asecond row of compressible tabs 1280.

In some embodiments, the distal end 1260 of the anchor body issubstantially rounded to facilitate insertion of the anchor body into abone tunnel and to slide around tendon positioned within the bonetunnel. A small hole 1290 may advantageously be provided in the centerof the distal end 1260 to facilitate engagement of the anchor body withan insertion tool, such insertion tool explained in subsequentparagraphs. The small hole 1290 may comprise threads to mate with thethreads on the inner rod of the insertion tool.

In one embodiment of the tissue anchoring device, a plurality ofcompressible tabs are located along the same axial position, formingcircumferential rows of compressible tabs. As shown in thecross-sectional view of FIG. 7A, the compressible tabs move about ahinge-like edge 1240, moving from a compressed state to an expandedstate upon insertion of the spreader 1300 through the proximal end 1250of the anchor body and into the central bore. In the expanded state, thecompressible tabs 1220 are substantially flush with the tubular wall andthe teeth 1230 protrude radially outwardly relative to the anchor body.

In another embodiment of the tissue anchoring device, there exists aplurality of compressible tabs 1220, wherein all compressible tabs areoffset axially relative to one another. FIG. 7B depicts across-sectional view of such an embodiment. With the compressible tabs1220 offset axially, such that no two tabs lie along the same axialposition, each tab can be configured to extend beyond the center line orcentral axis of the central bore when the tab is in its compressedstate. Such a configuration allows for the inclusion of larger teeth1230 on the compressible tab than would be possible with many otherembodiments, thus facilitating increased contact between the teeth andbone.

One embodiment, described in the preceding paragraph, is furtherillustrated in the perspective view provided in FIG. 8A. In FIG. 8A, theanchor body 1200 is shown in isolation with the compressible tabs 1220found in their compressed or undeployed state. The anchor body 1200 isgenerally tubular or cylindrical in shape and is comprised of a uniformdiameter. The compressible tabs 1220 bend inward along the bendable edge1240 such that the teeth 1230 are largely retracted into the centralbore inside the anchor body and do not extend substantially beyond thetubular wall 1210 prior to insertion of the spreader. The compressibletabs 1220 are offset both axially and circumferentially relative to eachother.

Another embodiment of a compressed or undeployed anchor body is shown inthe perspective view of FIG. 8B. In FIG. 8B, the central bore defined bythe tubular wall 1210 is visible from the proximal side of the anchorbody. The anchor body of this embodiment has an inner surface 1215 ofthe tubular wall which is in contact with a spreader 1300 when thespreader is inserted into the anchor body. In some embodiments, theinner surface 1215 may be smooth. In other embodiments, in inner surface1215 of the anchor body and the surface of the spreader 1300 may not besmooth, but rather, may be textured such as with a scallop shape orgrooves so as to inhibit movement of spreader 1300 once it is pushedinto the anchor body. In some embodiments, texturing in the innersurface 1215 is complementary to texturing in the outer surface of thespreader 1300. Such a design prevents unintended retraction orover-insertion of the spreader. In some embodiments, one or morecomplementary shapes, including multiple concentric grooves, a series ofprotruding ridges, or any other suitable complementary structures may bepresent on the inner surface 1215 of the anchor body 1200 and an outersurface of the spreader 1300 to lock the spreader 1300 into place whenthe anchor body 1200 is fully deployed in order to prevent unintendedretraction or over-insertion of the spreader 1300.

To provide further details of the spreader, an embodiment of thespreader is depicted in FIGS. 9A and 9B. The spreader 1300 may compriseany suitable shape configured to be inserted through the central bore ofthe anchor body 1200. In the embodiment of FIGS. 9A and 9B, thegenerally tapered distal end 1340 of the spreader is configured to comeinto contact with the compressible tabs of the anchor body andfacilitate bending of the tabs into their expanded state upon insertionof the spreader into the anchor body. The body 1310 of the spreader isuniformly tubularly shaped and surrounds an axial bore configured forreceiving an insertion tool. In this embodiment, the tubular body 1310of the spreader 1300 comprises a circumferentially located ridge 1325near its proximal end 1320. As the tissue anchoring device is deployed,the spreader 1300 is advanced into the anchor body 1200, spreading thecompressible tabs 1220 until the ridge 1325 of the spreader 1300 engagesthe groove 1225 in the inner surface of the anchor body. In oneembodiment, the ridge 1315 may be undercut providing even more securityagainst reversing. The proximal end of the spreader comprises agenerally flat face and a means for receiving the insertion tool. Forinstance, in this embodiment, the proximal end 1320 of the spreader 1300comprises a hole 1330 that receives the insertion tool. Afterdeployment, the spreader remains in the deployed anchor and theinsertion tool's inner rod shears off from the anchor body such that theproximal end of the spreader 1300 remains in the anchor in a state thatis either flush or slightly recessed with respect to the proximal end ofthe anchor body 1200.

The spreader 1300 will remain in the anchor body 1200 with thecompressible tabs 1220 in their fully expanded position. The forceprovided by the interaction between the compressible tabs, teeth andbone keeps the spreader 1300 tightly engaged. Further protection againstslipping or tilting of the spreader 1300 is provided by the optionallyridged sides of the spreader 1300. In one embodiment, one or more of thecompressible tabs 1220 have an indentation on a side facing the centralbore. A ridge on the spreader 1300 can then engage the indentation,thereby stabilizing the spreader 1300 and preventing the spreader 1300from being advanced too far into the anchor. In an alternativeembodiment, the spreader 1300 comprises an indentation that can engagewith a protrusion on a side of a compressible tab facing the centralbore. In addition to stabilizing the spreader 1300 and preventingover-insertion, this feature also prevents rotation of the spreader 1300relative to the anchor. Inserting the spreader 1300 into the anchor body1200 linearly, as opposed to twisting or screwing, is likely to beadvantageous in that the linear motion will create no tendency to rotatethe anchor. Thus, a linear approach is likely to prevent any twisting orturning of the captured soft tissue.

In one embodiment, illustrated in FIGS. 10A and 10B, the compressibletabs may be of a thin enough material thickness such that they can bepushed in by a slidable sleeve 1400 positioned over the anchor body1200. The slidable sleeve 1400 is configured to hold the compressibletabs 1200 in place substantially inside the anchor body 1200 duringinsertion of the anchor body 1200 into the bone tunnel. FIG. 10A showsone embodiment of the anchor body 1200 and slidable sleeve 1400combination with the anchor body 1200 in its compressed state and withthe combination connected to the outer tube 1600 of the insertion tool.The slidable sleeve 1400 can be withdrawn when the anchor body 1200 isin place inside a bone, and the compressible tabs will at leastpartially expand. The compressible tabs and teeth will completely expandaccording to the method described herein upon insertion of the spreader1300 using the insertion tool 3000. FIG. 10B depicts one embodiment ofthe anchor body 1200 and slidable sleeve combination with the slidablesleeve 1400 in a retracted state such that the compressible tabs 1220 ofthe anchor body 1200 have partially expanded and the teeth 1230partially protrude radially outward from the tubular wall. In thisdepiction, the spreader 1300 is held adjacent to the anchor body 1200via the inserter tool 3000 prior to insertion of the inserter into theanchor body 1200.

An additional embodiment of a tissue anchoring device 2100 is providedin FIGS. 11-14 . Similar to the tissue anchoring device 1100 embodimentdescribed above, the tissue anchoring device 2100 embodiment of FIG. 11is comprised of an anchor body 2200 and a spreader 2300. The spreader2300 is configured to slide or advance into a central bore 2265 of theanchor body 2200 without the need for applying torque.

As shown in FIG. 12 , in some embodiments, the anchor body 2200comprises a tubular wall 2210 defining a central bore 2265. In oneembodiment the tubular wall 2210 is uniformly tubular in that itcomprises a uniform diameter. In other embodiments, the tubular wall2210 is tapered such that a distal diameter is smaller than a proximaldiameter. The taper of some embodiments facilitates insertion of thetissue anchoring device 2100 into a bone tunnel. In some embodiments,the distal end 2260 of the anchor body 2200 is substantially rounded tofacilitate insertion of the anchor body into a bone tunnel and to slidearound tendon positioned within the bone tunnel. A small hole 2290 maybe provided in the center of the distal end 2260 to facilitateengagement of the anchor body with an insertion tool, such insertiontool explained in subsequent paragraphs. The small hole 2290 maycomprise threads to mate with the threads on the inner rod of theinsertion tool. In some embodiments, the proximal end 2270 of the anchorbody 2200 is cut on a slant, such that one side of the tubular anchorbody extends longitudinally beyond another side of the tubular anchorbody. Such a slant may be included on the proximal end 2270 when used ina bone tunnel having a slanted aperture at the entrance of the bonetunnel. Such a configuration may enable the proximal end 2270 of theanchor body 2200 to sit flush with a bone surface when a bone tunnel isdrilled into a bone on an angle, as is often done.

The anchor body 2200 of FIG. 12 also includes a proximal portion 2205that is outwardly expandable. As described in the previous anchor body1200 embodiment, expansion slots 2206 are cut into the anchor body 2200at the proximal end and extend in a distal direction such that theoutwardly expandable proximal portion 2205 comprises a plurality ofexpandable segments 2207 (i.e., expandable side portions) that aredisconnected from each other. Each expandable segment 2207 is connectedto the remainder of the anchor body 2200 (i.e., to a non-expandingdistal portion of the anchor body 2200) at a distal end of eachrespective expandable segment 2207. The expandable segments 2207 areconfigured to bend radially outward when the spreader 2300 is fullyadvanced distally into the central bore 2265 of the anchor body 2200. Insome embodiments, the tissue anchor 2100 is configured such that, whenthe tissue anchor 2100 is placed in a properly-sized bone hole, theoutwardly expandable proximal-most portion 2205 is positioned within thecortical layer of bone near the aperture of a bone tunnel. Theexpandable segments 2207 may be configured for cortical and/orsubcortical engagement. In various embodiments, each expandable segment2207 has a sharp edge, one or more ridges, teeth, or other protrusions2208, which facilitate engagement of the expandable segment 2207 withsurrounding bone.

Also shown in FIG. 12 , in some embodiments, the anchor body 2200 has aplurality of expandable segments 2220 (i.e., expandable side portions)located on a more distal half of the anchor body 2200. The expandablesegments 2220 are configured to be displaced radially outwardly (e.g.,bend outwardly) when a spreader is inserted into the central bore 2265of the anchor body 2200. The expandable segments are configured toengage with soft tissue and bone, fixedly securing the anchor body 2200and the soft tissue in the bone. In some embodiments, the expandablesegments 2220 comprise one or more protrusions 2222 (teeth, ridges,etc.) which are configured to further engage with the tissue and bone.The number of expandable segments 2220 and teeth 2222 can vary. Theexpandable segments 2220 are affixed to the tubular wall along an edge2224. The edge 2224 is configured to allow pivotal movement about thetubular wall 2210 such that the tines 2222 are bendable between acompressed state and an expanded state. In some embodiments, such asthat shown in FIG. 12 , the expandable segments 2220 and edges 2224 areoriented and configured such that upon expansion, a distal end of theexpandable segments 2220 experiences the greatest displacement.

FIG. 13 depicts the spreader 2300 of the tissue anchoring device 2100.In some embodiments, the spreader 2300 includes a conical portion 2310and a tubular portion 2320. In other embodiments, the spreader 2300 isentirely tubular or conical. In some embodiments, a flattened, groovedportion 2325, or similar feature, is present on an outer surface of thespreader 2300 to complement a feature within the central bore 2265 ofthe anchor body 2200, and thus align the orientation of the spreader2300 within the bore 2265. Such alignment features restrict axial androtational movement of the spreader 2300. The spreader 2300 of variousembodiments also includes a hole 2330 for receiving an insertion tool.

FIG. 14 depicts the tissue anchoring device 2100 in an expanded state.As in other embodiments, the spreader 2300 is insertable into thecentral bore 2265 at the proximal end of the anchor body 2200 andconfigured to urge the expandable segments 2220 and expandable proximalportion 2205 radially outward relative to the tubular wall 2210 uponinsertion of the spreader 2300 into the central bore. Such radialexpansion on both a proximal portion and a distal portion allows forimproved fixation of the tissue anchoring device 2100, includingfixation within a proximal aperture of a bone tunnel and a distalaperture of the bone tunnel.

In various embodiments of the tissue anchoring devices disclosed herein,the tissue anchoring device is made entirely of a biocompatibleengineering plastic. Other embodiments include a tissue anchoring devicemade entirely, or in part, of a biocompatible non-metallic substance.Biocompatible engineering polymer materials such aspolyether-ether-ketone, poly-ether-ketone, polyetherimide, ultrahighmolecular weight polyethylene, polyphenylene,poly(lactide-co-glycolide), polycaprolactone, or some otherbiocompatible polymer material known to those of skill in the art may beused. A non-metallic anchor system may provide certain advantages suchas, for example, eliminating MRI artifacts.

FIG. 15A depicts individual components of an inserter tool, which may,in some embodiments, be used with any tissue anchoring device designdisclosed herein. The inserter tool 3000 comprises an inner rod or tube3500, an outer tube 3600, a handle body 3700, a threaded actuator shaft3800, and a deployment knob 3900. In some embodiments, the inserter tool3000 is coupled to the tissue anchoring device 3100 duringmanufacturing. In a preferred embodiment, the inserter tool isdisposable.

The inserter tool 3000 is designed to insert and manipulate a tissueanchoring device, such the tissue anchoring device described above. Insome embodiments, the tissue anchoring device is manufactured to beattached to the inserter tool before packaging. In other embodiments,the tissue anchoring device is coupled to the inserter tool shortlyprior to insertion. In a basic configuration, the inserter tool isassembled as follows: the inserter tool 3000 is configured such that theinner rod 3500 is disposed within the outer tube 3600. The outer tube isconfigured to fit against the proximal end of the spreader 3300. Theinner rod 3500 extends through outer tube 3600 and is configured toattach to the distal end of the anchor body 3200 via threading on boththe distal hole in the anchor body 3200 and threading on the distal endof the inner rod 3500. The proximal end of the outer tube 3600 isconnected to a handle 3700 and the inner rod 500 extends through theproximal end of the outer tube 3600 and screws into the threadedactuator shaft 3800. The actuator shaft 3800 extends just past theproximal end of the handle 3700 where it is configured to secure with adeployment knob 3900.

The individual components of the inserter tool 3000 arc furtherdescribed in detail below. The inserter tool 3000 may be used with anyembodiment of a tissue anchoring device. For ease of description, in thedescription that follows, the inserter tool 3000 is described withreference to tissue anchoring device 100.

FIG. 15B shows a perspective view of an embodiment of the inner rod3500. In some embodiments, the inner rod is an inner tube. The inner rodcomprises a rod-like or tube-like body 3525, a distal end 3510configured to secure to a tissue anchoring device spreader 300, and aproximal end 3520 which is configured to interact with the othercomponents of the inserter such as the actuator shaft 3800. The innerrod 3500 is configured such that a proximal end 3520 is advanced throughthe outer tube 3600 and into the handle 3700 where it is further securedwithin the actuator shaft 3800 via threading. The distal end of theinner rod 3500 is configured to extend through the central bore in aspreader 300 and an anchor body 200 and then be secured to the distalend of the anchor body 200. Upon activation, the inner rod is retracteduntil the tissue anchoring device is fully deployed and the inner rod isseparated from the anchor.

The inner rod 3500 extends through the central bore in the spreader 300and the anchor body 200 before coupling with the distal end of theanchor body 200. In one embodiment, the inner rod 3500 couples with theanchor body 200 through threads 3505 on the end of the inner rod 3500and within the distal end of the anchor body 200. In other embodiments,the inner rod 3500 may couple to the anchor body 200 through othersecuring mechanisms such as adhesives, welding or frictional fit.

FIG. 15C shows an embodiment of the outer tube 3600. The outer tube 3600is attached at its proximal end 3605 to the distal end of handle 3700via threading 3625. The distal end 3610 of the outer tube 3600 isconfigured such that the inner rod 3500 can be drawn into the outer tube3600 through the distal end 3610 of outer tube 3600. When the inner tube3500 is advanced far enough that the spreader 300 locks into place orcannot advance anymore, the distal surface of the outer tube 3600 may belevel with the proximal surface of the anchor body 200. When the innerrod 3500 withdraws further into the outer tube upon the continuedrotation of the deployment knob and advancement of the actuator shaft,the inner rod 3500 strips the threading from the anchor body 200 and theinserter tool 3000 detaches from the tissue anchoring device 100.

FIGS. 15D and 15E show embodiments of a handle body 3700. FIG. 15D is across-sectional view of one embodiment of a handle 3700 and 15E is acut-away view of the handle body 3700. The proximal end of the handle3700 is configured to receive the deployment knob 3900 via the ridges3730 which hold the knob 3900 secure. The actuator shaft 3800 is housedwithin the handle body 3700. A set of brackets or braces 3710 eachhaving a flat surface 3715 secure the actuator shaft 3800 within thehandle 3700. The distal end 3770 of the handle is configured to receivethe outer tube 3600 via threads 3725 in opening 3740. The outer tube3600 is permanently affixed to the handle 3700 at its distal end.

FIG. 15F depicts the threaded actuator shaft 3800. The actuator shaft3800 is comprised of a distal end 3805 comprising a threaded hole 3810which is configured to receive the inner rod 3500, a second threadedportion 3825 on the body of the shaft configured to advance the innerrod 3500, and a proximal end 3820 configured to secure within thedeployment knob 3900. The threading 3825 of the actuator 3800 has twoflat areas 3830, one on each side, where there is no threading. Theseflat areas 3830 fit within the flat brackets 3710 of the handle suchthat the actuator 3800 cannot rotate within the handle.

The body of the actuator shaft 3800 is configured with threading 3825 topermit the shaft 3800 to advance the inner tube 3500. The body of theactuator shaft 3800 is not perfectly round, but rather is oval shapedwith flat sides 3830 that fit into the handle body 3700 in such a waythat the actuator shaft 3800 cannot itself rotate when the deploymentknob 3900 is turned and the shaft 3800 advances via knob 3900. Thus, thethreads do not go all the way around the shaft but rather flatten out onthe flattened sides of the shaft. The actuator shaft is configured as acoaxial system. That is, the spreader 3300, inner tube 3500 and actuator3800 are configured to operate as one piece. The flat brackets 3710 inthe handle make the actuator shaft 3800 stay on plane such that theactuator shaft 3800 itself cannot rotate within the handle 3700. Theproximal end of the inner tube 3500 couples with the distal end of theactuator shaft 3800 via threading.

FIG. 15G depicts a deployment knob 3900. The deployment knob 3900comprises a central hole 3910 which is configured with threading 3905,and a groove 3930 configured to be received by a corresponding ridge3730 of the handle 3700. The threading 3905 in the central hole 3910 isconfigured to receive the actuator shaft 3800. The deployment knob 3900is configured to advance, relative to the deployment knob 3900, theinner rod 3500 via the actuator shaft 3800. The actuator shaft 3800 isjoined at its proximal end to the distal end of the deployment knob 3900via threading 3905 in the central hole 3910. The actuator shaft 3800 isattached to the inner rod 3500 by way of the proximal end of the innerrod 3500 advancing into the distal end of the actuator shaft viathreading so that when the deployment knob 3900 is rotated, themechanism of the shaft 3800 advances the inner rod 3500 proximally suchthat the spreader 300 is then advanced into the anchor body 200 toexpand the anchor body 200 into bone and secure the tissue anchoringdevice 100.

In one embodiment, the deployment knob 3900 is threaded 3905 to receivethe actuator shaft via the groove 3930 of knob 3900 fitting with theproximal end ridge 3730 of the handle body 3700. As the deploymenthandle is turned, the actuator shaft 3800 is advanced in a proximaldirection until the anchor body 200 is deployed and locked into place.

When in the position for deployment, the inner rod 3500 is positionedwithin the outer tube 3600, and the outer tube is flush with the anchorbody 200. The inner rod 3500 may hold the anchor body 200 steady duringinsertion and deployment. The inner rod 3500 extends through thespreader 300 and couples to the anchor body 200 via threading. Thespreader 300 is configured to be advanced distally through the proximalend of the anchor body 200 by the retraction of the inner rod 3500 viarotating the deployment knob 3900, which pulls the anchor body 200proximally relative to the spreader 300.

The outer tube 3600 provides the mechanism to push the spreader 300 intothe central bore 265 in the anchor body 200 to fully expand the anchorbody 200. During deployment of the tissue anchoring device, the innerrod 3500 is continually retracted via a screwing motion until thespreader 300 locks into the anchor body 200. As the deployment knob 3900continues to turn and the inner rod 3500 continues to pull on thethreads of the anchor body 200, the inner rod 3500 strips the threadsfrom the inside of the anchor body 200 and the insertion tool 3000releases from the anchor body 200. Any thread shavings are containedwithin the outer tube 3600.

In some embodiments, a pre-attached delivery handle is provided. In someembodiments, the insertion tool or delivery handle is disposable. Inother embodiments, the insertion tool can be sterilized, reloaded, andreused.

Those of skill in the art will appreciate other inserters and mechanismsthat may be used to insert and deploy the tissue securing anchordescribed herein. Although a particular insertion device for insertingand manipulating a tissue anchoring device has been described, it shouldbe understood that other inserter designs may be used for manipulatingthe tissue anchoring device described above in order to insert theanchor and soft tissue into bone. For example, it may be possible to useseparate tools for inserting the anchor, securing soft tissue, andsecuring the anchor.

The anchors described above may be used to secure a tissue graft in anACL repair. In some embodiments, the anchors described above are used toanchor tissue in a bone tunnel in the tibia. In such procedures, thetissue graft is first anchored within a bone tunnel in the femur. Anysuitable anchor may be used to secure tissue to the femur. In someembodiments, suitable anchors include a tissue grasping feature that canbe used to capture tissue and feed it through bone tunnels in the tibiaand/or femur. In some embodiments, the tissue grasping feature includesa suture loop that can be tightened around one or more strands oftissue.

One example of such a suture loop anchor 4000 is depicted in FIGS. 16Aand 16B and described in more detail in FIGS. 13A-16B in U.S. PatentApplication Publication No. 2011-0112550, which is incorporated hereinby reference in its entirety. FIG. 16A depicts the femoral anchor 4000in an undeployed state with suture loop ready to capture tissue. Aftertissue capture and insertion in the femur, lateral protrusions on theanchor 4000 may be deployed to secure the anchor and issue into thefemur. FIG. 16B depicts the femoral anchor 4000 in its deployed state.

In other embodiments, a modified version of the tibial anchor describedabove may be used as the femoral anchor. One such embodiment of afemoral anchor 5000 is depicted in FIG. 17 . In this case, instead of arounded distal end, the anchor body 5100 comprises a flat, depressed, orsaddle shaped distal end 5106. Two apertures or provided in the distalend 5106 to accommodate the treading of a suture to form a suture loop5200 in the distal end. As in the anchor described in FIGS. 16A and 16B,tissue may be captured within the suture loop 5200, the suturetightened, and then the anchor 5000 with captured tissue inserted intothe femoral bone tunnel. The anchor 5000 may be deployed using the samespreader and inserter as described above for the tibial anchor.

Those of skill in the art will appreciate other suitable femoral anchorsfor use in combination with the tibial anchor described herein inperforming a torn ACL repair.

FIGS. 18A-18D depict some non-limiting suitable ACL repair techniquesutilizing the anchors described herein. First, as depicted in FIG. 18A,a bone tunnels 6100 and 6200 are formed in the tibia and femur,respectively. In some embodiments, both tunnels 6100 and 6200 are formedusing a single drill drilling through the tibia and then into the femur.In other embodiments, the femoral tunnel 6200 and tibial tunnel 6100 maybe formed separately. Next, a surgeon obtains a suitable tissue graft6300, which may include tendon from the patient (e.g., one or morepatellar or hamstring tendons), from a cadaver, or a synthetic graft.The tissue graft 6300 is then captured by a femoral anchor 1100, suchas, for example, any of the anchors 4000, 5000 described in FIGS. 16A-17. The femoral anchor 4000 (as an example) is then inserted into thefemoral tunnel 6200 and deployed to secure the graft 6300 into thefemur.

In one embodiment, as depicted in FIG. 18B, a lateral technique is usedwhereby the surgeon inserts the femoral anchor 4000 with captured tissuegraft 6300 laterally into the space between the femur and tibia. Thefemoral anchor 4000 is then inserted directly into the femoral bonetunnel 6200. The joint may be abducted to facilitate direct insertion inthe femoral tunnel 6200. After insertion of the femoral anchor 4000, thetissue graft 6300 may then be fed down through the tibial bone tunnel6100 and out the other side resulting in the configuration depicted inFIG. 18C. In one technique, a suture loop is fed up through the tibialtunnel 6100, the graft 6300 is fed through the loop, and then the loopis pulled back through the tibial tunnel 6100, drawing the graft 6300with it.

In an alternative embodiment, an in-line approach may be used where thefemoral anchor 4000 with captured tissue graft 6300 is inserted throughthe tibial bone tunnel 6100 and then into the femoral bone tunnel 6200.The result is graft 6300 running from the femoral anchor 4000 throughand out of the tibial tunnel 6100 as depicted in FIG. 18C.

After achieving the configuration of FIG. 18C, the joint may bepositioned and the tissue graft 6300 tensioned as appropriate. Next, asdepicted in FIG. 18D, a tibial anchor (for example, tibial anchor 100)as described herein may be inserted into the opening of the tibial bonetunnel 6100 and deployed to secure the graft 6300 to the tibia. Excessgraft 6300 may then be trimmed to be flush with the tibial anchor 100.As shown in FIG. 18D, in some embodiments, the tibial anchor 100 isconfigured to extend substantially the length of the tibial bone tunnel6100. In some embodiments of the tissue anchoring device 100 disclosedherein, expansion of the tibial anchor 100 is relatively uniform. Inother embodiments, the tissue anchoring device is configured to expandat various locations along the length of the tibial anchor 100. Thus,the use of any of the above-described tibial anchors for ACL repairprocedures may advantageously allow for fixation of the tissue to bonethroughout the length of the tibial bone tunnel 6100. In variousembodiments, the length of the anchor is greater than about 30 mm,greater than about 35 mm, greater than about 40 mm, or about 45 mm.

In one embodiment of a method of ACL repair, the tibial anchor 100 maybe inserted into the opening of the tibial bone tunnel 6100 and pushedthrough distally until at least a distal tip of the tibial anchor 100emerges on the other side of the tibial bone tunnel 6100. In suchembodiments, the tibial anchor 100 is then pulled proximally back untilthe distal tip of the tibial anchor 100 is no longer visible. Such aninsertion mechanism ensures the tibial anchor 100 is properly sized andplaced in the bone tunnel such that the tibial anchor 100 extendssubstantially the length of the tibial bone tunnel 6100. In someembodiments, such placement will allow for aperture fixation of thetibial anchor 100 at both a distal opening and a proximal opening of thetibial bone tunnel 6100.

Additionally or alternatively, in one embodiment of a method of ACLrepair, the tibial bone tunnel 6100 is measured to determine its length.In some such embodiments, a measurement tool or guide is inserted intothe tibial bone tunnel 6100 after formation. The length of the bonetunnel 6100 is detected, and an appropriately-sized tibial anchor (forexample, tibial anchor 100) is selected to fit substantially the entirelength of the bone tunnel 6100. The anchors and tissue are then insertedin accordance with the methods described in relation to FIGS. 18B-18D.In some such embodiments, an anchor having a length greater than 25 mmis selected. In some embodiments, an anchor having a length ofapproximately 30 mm, 45 mm, 50 mm, or any value there between isselected.

Advantageously, aperture fixation at both a distal opening and aproximal opening of the tibial bone tunnel 6100 may allow for engagementof the tibial anchor 100 (and consequently, the tissue 6300) with bothcancellous bone and cortical bone at both ends of the tibial anchor 100.Fixation within the softer outer bone portion of the tibia may lead tobetter bone growth around the anchor 100 and the tissue, ensuring asecure connection at both ends. In some embodiments, aperture fixationof the tibial anchor at both the distal and proximal sides helpsminimize wear on, and irritation of, the tissue 6300; it may reduce the“windshield wiper” effect that can occur when one end of an anchorloosens; and it may also improve the healing process and reduce the riskof anchor failure by increasing the contact between the tissue 6300 andthe tibial bone.

In some embodiments, the approach described above is conducted using asingle strand of tissue graft 6300. In this case, the graft 6300 may becaptured by the femoral anchor 4000 and doubled over the end of thefemoral anchor 4000 such that two parallel portions of the graft 6300run from the femoral anchor 4000 to the tibial anchor 100. In otherembodiments, two strands of tissue graft 6300 may be doubled over theend of the femoral anchor 4000 resulting in four parallel portions ofgraft 6300 running from the femoral anchor 4000 to the tibial anchor100.

Although ACL repair techniques have been described herein, it will beappreciated that the anchors described may be used in any number ofprocedures where a surgeon desires to fix soft tissue to bone.

For purposes of summarizing the disclosure, certain aspects, advantagesand features have been described herein. It is to be understood that notnecessarily all such advantages may be achieved in accordance with anyparticular embodiment. Thus, the invention may be embodied or carriedout in a manner that achieves or optimizes one advantage or group ofadvantages as taught herein without necessarily achieving otheradvantages as may be taught or suggested herein.

While this invention has been described in connection with what arepresently considered to be practical embodiments, it will be appreciatedby those skilled in the art that various modifications and changes maybe made without departing from the scope of the present disclosure. Itwill also be appreciated by those of skill in the art that parts mixedwith one embodiment arc interchangeable with other embodiments; one ormore parts from a depicted embodiment can be included with otherdepicted embodiments in any combination. For example, any of the variouscomponents described herein and/or depicted in the Figures may becombined, interchanged or excluded from other embodiments. With respectto the use of substantially any plural and/or singular terms herein,those having skill in the art can translate from the plural to thesingular and/or from the singular to the plural as is appropriate to thecontext and/or application. The various singular/plural permutations maybe expressly set forth herein for sake of clarity.

While the present disclosure has described certain exemplaryembodiments, it is to be understood that the invention is not limited tothe disclosed embodiments, but, on the contrary, is intended to covervarious modifications and equivalent arrangements included within thescope of the appended claims, and equivalents thereof.

What is claimed is:
 1. An expandable bone anchor, comprising: an anchorbody comprising: a plurality of first expandable side portionspositioned at a proximal end of the anchor body, wherein the firstexpandable side portions expand by bending outward such that each of thefirst expandable side portions extends outward to a greater extent atits proximal portion than at its distal portion; and a plurality ofsecond expandable side portions positioned distally of the firstexpandable side portions, wherein the second expandable side portionsexpand by bending outward such that each of the second expandable sideportion extends outward to a greater extent at its distal portion thanat its proximal portion; and a spreader configured to advance distallyinto the anchor body, thereby causing the first and second expandableside portions to expand outward.
 2. The anchor of claim 1, wherein theanchor body further comprises a distal tapered anchor tip.
 3. The anchorof claim 1, wherein the spreader is coupled to the side portions.
 4. Theanchor of claim 3, wherein the spreader is slidably coupled to the sideportions.
 5. The anchor of claim 3, wherein the spreader comprises aplurality of longitudinal grooves and each side portion is coupled toone of the grooves such that the side portions can slide longitudinallyalong the grooves.
 6. The anchor of claim 1, wherein the spreadercomprises at least a portion that is tapered distally.
 7. The anchor ofclaim 1, wherein the first and second expandable side portions comprisebone engaging features.
 8. The anchor of claim 7, wherein the boneengaging features comprise teeth.
 9. The anchor of claim 7, wherein thebond engaging features comprise ridges.
 10. The anchor of claim 1,wherein at least one of the first side portions and the second sideportions is formed by cuts in a side wall of the anchor body.
 11. Theanchor of claim 1, wherein the spreader has a substantially constantdiameter along its length.
 12. The anchor of claim 1, wherein thespreader comprises a circumferential ridge positioned at or adjacent toits proximal end.
 13. The anchor of claim 1, wherein the anchor tip hasa hemispherical shape.
 14. The anchor of claim 1, wherein the anchor tiphas a conical shape.